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The Ontario Drug Benefit (ODB) program is the public drug funding system of Ontario. It covers 4,400 prescription drugs products contained in the provincial formulary. In addition to the formulary drugs listed, there are additional drugs under the Exceptional Access Program (EAP). This is a branch of the ODB program where funding of specific drugs for a specific purpose are requested by a physician and approved through a review process. A list of drugs accessed through EAP can be seen here: Many oncology and hematology medications are obtained through the EAP process. These resources are not under the control of the Government of Canada and the link is provided solely for the convenience of our website visitors. We are not responsible for the accuracy, currency or reliability of the content of this website. The Government of Canada does not offer any guarantee in that regard and is not responsible for the information found through this link. Visitors should also be aware that information offered by this non-Government of Canada site is not subject to the Privacy Act or the Official Languages Act and may not be accessible to persons with disabilities. The information offered may be available only in the language used by the site. With respect to privacy, visitors should research the privacy policies of this non-government website before providing personal information. Page 2 URL: http:_extract.xml Page 3 URL: http:_extract.xml (Received from the Ministry January 24, 2018) We are pleased to provide you with the Summary of Changes – January 2018 to Edition No. 43 of the Ontario Drug Benefit (ODB) Formulary Comparative Drug Index (Formulary), which becomes effective January 31, 2018. The Edition No. 43 document will be posted on the Ministrys website http:_43.aspx by January 31, 2018. The information in this Summary of Changes – January 2018 is based on the decisions made by the Executive Officer, taking into consideration recommendations from the Ministrys expert advisory committee, the Committee to Evaluate Drugs (CED). Listing Changes – 1 existing single source drug with Limited Use criteria change (1 DIN) – 4 multiple source drugs (6 DINs) – 1 new Off-Formulary Interchangeable (OFI) generic drug (1 DIN) – 1 drug (1 DIN) has an additional dosage format funded and one drug (1 DIN) has its funding criteria modified in the Exceptional Access Program (EAP) – 4 drugs (8 DINs) transitioned from the Exceptional Access Program (EAP) to the Formulary – 1 change in Limited Use (LU) criteria Single Source Drug Prolia (denosumab) 60mgmL Inj Sol-Pref Syr (AMG) Limited Use (LU) Criteria Revised LU criteria content for LU Codes 428 and 429 (for female patients) New LU Codes 515 and 516 (for male patients) Please see the Summary of Changes (SOC) document for details of the LU criteria New Multiple Source Drug Products ACT BuprenorphineNaloxone 2mg0.5mg, 8mg2mg SL Tab ACV CCP-Letrozole 2.5mg Tab CCP Mylan-Propafenone 150mg, 300mg Tab MYL Sandoz Moxifloxacin 400mg Tab SDZ Exceptional Access Program (EAP) Products Cimzia (certolizumab pegol) 200mgmL Inj Sol – Pref Pen (UCB) – Effective Date: January 31, 2018 New prefilled pen dosage format added to existing funded prefilled syringe format. No changes to funding criteria or Drug Benefit Price (DBP). Imbruvica (ibrutinib) 140mg Cap (JAN) – Effective Date: December 28, 2017 The relapsed and refractory Mantle Cell Lymphoma (MCL) indication is now funded for eligible patients according to clinical criteria. The existing clinical criteria for Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) have been revised to include first line treatment in previously untreated patients. The reimbursement criteria for the above product will be included on the list of Frequently Requested Drugs, which can be found on the Ministrys website: http:_requested_drugs.pdf Transition from the Exceptional Access Program (EAP) to the Formulary From the EAPs Palliative Care Facilitated Access (PCFA) mechanism to the Formulary as Limited Use (LU) drugs Morphine Sulfate 2mgmL, 10mgmL Inj Sol SDZ Phenobarbital Sodium Injection USP 120mgmL Inj Sol SDZ LU Code 481 For the management of patients receiving palliative care*. LU Authorization Period: 1 year NOTE: *The patient must have a progressive life-limiting illness and require this medication for palliative purposes. From the EAP to the Formulary as General Benefit (GB) drugs Phenobarb 15mg, 30mg, 60mg, 100mg Tab PEN Phenobarb Elixir 5mgmL Oral Elixir PEN Revised Limited Use (LU) Criteria Applies to various strengths of Aptiom (eslicarbazepine acetate), Fycompa (perampanel) and Vimpat (lacosamide). Please see the SOC document for details. Revised LU Code 430 As adjunctive therapy in the treatment of patients with partial onset seizures who have had an inadequate response or have significant intolerance to at least 3 less costly anticonvulsant therapies; AND Patients are under the care of a physician experienced in the treatment of epilepsy. Note: Less costly anticonvulsant therapies may include the following: Phenytoin, Carbamazepine, Gabapentin, Lamotrigine, Vigabatrin, Topiramate, etc. LU Authorization Period: Indefinite The Ministry has posted a new file with the listing changes for download and review (Edition No. 43, Summary of Changes – January 2018). It is accessible from the Ministrys website: http:_43.aspx. In addition, the Formulary, Summaries of Changes and Bulletins, including a searchable electronic version of the Formulary (e-Formulary), are also accessible from the ministrys website: https: – The e-Formulary will be updated on the effective date – January 31, 2018. We appreciate your continued cooperation in making these benefit adjustments.

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